An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (SUNSCAPE-1)

April 23, 2026 updated by: Sanofi

A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis.

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:

The study duration may be up to 35 weeks with:

Screening period
12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)
12-week Sub-Study 3 (Extended Induction for non-responders)
45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)

The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Study Overview

Status

Recruiting

Conditions

Ulcerative Colitis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

980

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Trial Transparency email recommended (Toll free for US & Canada)
Phone Number: option 6 800-633-1610
Email: contact-us@sanofi.com

Study Locations

Bulgaria
- - Rusa, Bulgaria, 7002
    - Recruiting
    - Investigational Site Number : 1000007
  - Sofia, Bulgaria, 1343
    - Recruiting
    - Investigational Site Number : 1000008
  - Sofia, Bulgaria, 1618
    - Recruiting
    - Investigational Site Number : 1000001
Canada
- - Hamilton, Canada, L8N 1Y2
    - Recruiting
    - Charlton Digestive Disease Centre - Site Number : 1240009
  - Oakville, Canada, L6L 5L7
    - Recruiting
    - Oakville Endoscopy Center Inc. DBA ABP Research Services Corp. - Site Number : 1240010
  - Toronto, Canada, M6A 3B4
    - Recruiting
    - Toronto Immune and Digestive Health Institute Inc. (TIDHI) - Site Number : 1240003
China
- - Chengdu, China, 610065
    - Recruiting
    - Investigational Site Number : 1560001
Czechia
- - Hradec Králové, Czechia, 500 12
    - Recruiting
    - Investigational Site Number : 2030011
France
- - Lille, France, 59000
    - Recruiting
    - Investigational Site Number : 2500010
  - Nice, France, 6200
    - Recruiting
    - Investigational Site Number : 2500013
  - Vandœuvre-lès-Nancy, France, 54511
    - Recruiting
    - Investigational Site Number : 2500006
Georgia
- - Kutaisi, Georgia, 4600
    - Recruiting
    - Investigational Site Number : 2680007
  - Tbilisi, Georgia, 180
    - Recruiting
    - LLC The First Medical Center - Site Number : 2680004
  - Tbilisi, Georgia, 180
    - Recruiting
    - Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002
  - Tbilisi, Georgia, 102
    - Recruiting
    - Investigational Site Number : 2680006
  - Tbilisi, Georgia, 144
    - Recruiting
    - Investigational Site Number : 2680008
  - Tbilisi, Georgia, 160
    - Recruiting
    - Investigational Site Number : 2680005
  - Tbilisi, Georgia, 180
    - Recruiting
    - Investigational Site Number : 2680003
Germany
- - Berlin, Germany, 14163
    - Recruiting
    - Investigational Site Number : 2760003
  - Herne, Germany, 44623
    - Recruiting
    - Investigational Site Number : 2760026
  - Kiel, Germany, 24105
    - Recruiting
    - Investigational Site Number : 2760001
  - Leipzig, Germany, 4103
    - Recruiting
    - Investigational Site Number : 2760015
  - Minden, Germany, 32423
    - Recruiting
    - Investigational Site Number : 2760010
  - Ulm, Germany, 89081
    - Recruiting
    - Investigational Site Number : 2760005
Hungary
- - Budapest, Hungary, 1066
    - Recruiting
    - Investigational Site Number : 3480004
Japan
- - Asahikawa, Japan, 070-8610
    - Recruiting
    - Asahikawa City Hospital - Site Number : 3920011
  - Asahikawa, Japan, 078-8510
    - Recruiting
    - Investigational Site Number : 3920005
  - Bunkyō City, Japan, 113-8655
    - Recruiting
    - The University of Tokyo Hospital - Site Number : 3920059
  - Chikushino-shi, Japan, 818-8502
    - Recruiting
    - Investigational Site Number : 3920039
  - Chūō, Japan, 104-0061
    - Recruiting
    - Investigational Site Number : 3920021
  - Fukuoka, Japan, 815-8555
    - Recruiting
    - Japanese Red Cross Fukuoka Hospital - Site Number : 3920027
  - Kagoshima, Japan, 892-0843
    - Recruiting
    - Kagoshima IBD Gastroenterology Clinic - Site Number : 3920049
  - Kamakura, Japan, 247-0056
    - Recruiting
    - Ofuna Chuo Hospital - Site Number : 3920029
  - Kanazawa, Japan, 920-8650
    - Recruiting
    - National Hospital Organization Kanazawa Medical Center - Investigational Site Number : 3920010
  - Kashiwa, Japan, 277-0871
    - Recruiting
    - Kokikai Tsujinaka Hospital Kashiwanoha - Site Number : 3920031
  - Kobe, Japan, 650-0015
    - Recruiting
    - Aoyama Clinic, Site Number : 3920018
  - Kumamoto, Japan, 860-0004
    - Recruiting
    - Hattori Clinic - Site Number : 3920051
  - Nagaoka, Japan, 940-2085
    - Recruiting
    - Nagaoka Red Cross Hospital - Site Number : 3920041
  - Okayama, Japan, 703-8511
    - Recruiting
    - Investigational Site Number : 3920008
  - Osaka, Japan
    - Recruiting
    - National Hospital Organization Osaka National Hospital - Investigational Site Number : 3920002
  - Osaka, Japan, 532-0003
    - Recruiting
    - Investigational Site Number : 3920050
  - Panevezys, Japan, 35144
    - Recruiting
    - Public Institution Panevezys Republican hospital - Site Number : 4400002
  - Saga, Japan, 849-8501
    - Recruiting
    - Investigational Site Number : 3920014
  - Sakura, Japan, 285-8741
    - Recruiting
    - Investigational Site Number : 3920023
  - Sapporo, Japan, 004-0041
    - Recruiting
    - Sapporo Tokushukai Hospital - Site Number : 3920019
  - Sapporo, Japan, 065-0033
    - Recruiting
    - Sapporo Higashi Tokushukai Hospital - Investigational Site Number : 3920042
  - Sapporo, Japan, 062-8618
    - Recruiting
    - Investigational Site Number : 3920056
  - Sendai, Japan
    - Recruiting
    - National Hospital Organization Sendai Medical Center - Investigational Site Number : 3920003
  - Sendai, Japan, 981-3213
    - Recruiting
    - Takagi Clinic - Site Number : 3920004
  - Shinjuku, Japan, 162-8655
    - Recruiting
    - National Center for Global Health and Medicine - Site Number : 3920038
  - Shiwa-gun, Japan, 028-3695
    - Recruiting
    - Iwate Medical University Hospital - Site Number : 3920020
  - Tokyo, Japan, 192-0032
    - Recruiting
    - Tokai University Hachioji Hospital - Site Number : 3920030
  - Toyama, Japan, 930-0194
    - Recruiting
    - Toyama University Hospital - Site Number : 3920032
  - Toyama, Japan, 930-8550
    - Recruiting
    - Toyama Prefectural Central Hospital - Site Number : 3920037
  - Toyohashi, Japan, 441-8570
    - Recruiting
    - Investigational Site Number : 3920015
  - Tsu, Japan, 514-8507
    - Recruiting
    - Mie University Hospital - Investigational Site Number : 3920009
  - Yokohama, Japan, 232-0024
    - Recruiting
    - Investigational Site Number : 3920035
Lithuania
- - Kaunas, Lithuania, LT-50161
    - Recruiting
    - Investigational Site Number : 4400001
Moldova
- - Chisinau, Moldova, MD-2025
    - Recruiting
    - Investigational Site Number : 4980003
  - Chisinau, Moldova, MD-2025
    - Recruiting
    - PMSI 'Timofei Mosneaga' Republican Clinical Hospital - Site Number : 4980002
  - Chisinau, Moldova, MD-2068
    - Recruiting
    - 'Sfanta Treime' Municipal Clinical Hospital - Site Number : 4980004
Poland
- - Elblag, Poland, 82-300
    - Recruiting
    - Investigational Site Number : 6160013
  - Katowice, Poland, 40-748
    - Recruiting
    - Investigational Site Number : 6160014
  - Krakow, Poland, 31-506
    - Recruiting
    - Investigational Site Number : 6160022
  - Lodz, Poland, 90-752
    - Recruiting
    - Investigational Site Number : 6160016
  - Poznan, Poland, 60-309
    - Recruiting
    - Investigational Site Number : 6160018
  - Rzeszów, Poland, 35-055
    - Recruiting
    - Investigational Site Number : 6160025
  - Sopot, Poland, 81-756
    - Recruiting
    - Endoskopia Sp. z o.o. (LLC) - Site Number : 6160004
  - Staszów, Poland, 28-200
    - Recruiting
    - New health-CK, Kieltucki and partners g.p. - Site Number : 6160007
  - Szczecin, Poland, 71-685
    - Recruiting
    - SONOMED - Site Number : 6160020
  - Szczecin, Poland, 71-434
    - Recruiting
    - Investigational Site Number : 6160002
  - Wadowice, Poland, 34-100
    - Recruiting
    - Investigational Site Number : 6160012
  - Warsaw, Poland, 00-189
    - Recruiting
    - Investigational Site Number : 6160005
  - Warsaw, Poland, 00-189
    - Recruiting
    - Investigational Site Number : 6160006
  - Warsaw, Poland, 01-595
    - Recruiting
    - Investigational Site Number : 6160031
  - Wrocklaw, Poland, 53-611
    - Recruiting
    - Investigational Site Number : 6160028
Puerto Rico
- - Vega Baja, Puerto Rico, 00693
    - Recruiting
    - Wellness Clinical Research - Vega Baja - Site Number: 8400099
Serbia
- - Belgrade, Serbia, 11,000
    - Recruiting
    - Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Gastroenterology and Hepatology -Site Number : 6880001
  - Belgrade, Serbia, 11080
    - Recruiting
    - Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine, Department of Gastroenterology and Hepatology -Site Number : 6880002
  - Belgrade, Serbia, 11000
    - Recruiting
    - Clinical Hospital Center 'Dr. Dragisa Misovic-Dedinje' - Site Number : 6880007
  - Belgrade, Serbia, 11000
    - Recruiting
    - University Clinical Center of Serbia - Site Number : 6880006
  - Niš, Serbia, 18000
    - Recruiting
    - Investigational Site Number : 6880004
Slovakia
- - Bratislava, Slovakia, 811 09
    - Recruiting
    - Investigational Site Number : 7030001
South Africa
- - Claremont, South Africa, 7708
    - Recruiting
    - Investigational Site Number : 7100005
  - Durban, South Africa, 3610
    - Recruiting
    - Investigational Site Number : 7100004
  - Kempton Park, South Africa, 1619
    - Recruiting
    - Investigational Site Number : 7100001
Switzerland
- - Bern, Switzerland, 3012
    - Recruiting
    - Investigational Site Number : 7560001
Taiwan
- - Chiayi City, Taiwan, 60002
    - Recruiting
    - Investigational Site Number : 1580003
  - Taipei, Taiwan, 100226
    - Recruiting
    - National Taiwan University Hospital - Site Number : 1580002
Ukraine
- - Chernivtsi, Ukraine, 58001
    - Recruiting
    - Bukovinian State Medical University - Site Number : 8040003
  - Kyiv, Ukraine, 2002
    - Recruiting
    - Limited Liability Company 'Edelweiss Medics' - Site Number : 8040001
  - Kyiv, Ukraine, 3037
    - Recruiting
    - Limited Liability Company 'Medbud-Clinic' - Site Number : 8040002
  - Kyiv, Ukraine, 2091
    - Recruiting
    - Investigational Site Number : 8040013
  - Lviv, Ukraine, 79000
    - Recruiting
    - University Hospital of the State Non-Profit Enterprise 'Danylo Halytsky Lviv National Medical University' - Site Number : 8040004
  - Lviv, Ukraine, 79010
    - Recruiting
    - State Non-Profit Enterprise 'Danulo Halytsky National Medical University in Lviv' - Site Number : 8040012
  - Lviv, Ukraine, 79019
    - Recruiting
    - Limited Liability Company 'PROGASTRO CLINIC' - Site Number : 8040005
  - Uzhhorod, Ukraine, 88000
    - Recruiting
    - Public Non-Profit Enterprise 'Andrii Novak Zakarpattia Regional Clinical Hospital' under Zakarpattia Regional Council - Site Number : 8040006
  - Vinnytsia, Ukraine, 21013
    - Recruiting
    - Limited Liability Company 'Center of Gastroenterology and Dietology' - Site Number : 8040010
  - Vinnytsia, Ukraine, 21028
    - Recruiting
    - National Pirogov Memorial Medical University - Site Number : 8040009
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - National Pirogov Memorial Medical University - Site Number : 8040008
United States
- Arizona
  - Peoria, Arizona, United States, 85381
    - Recruiting
    - Onyx Clinical Research - Site Number: 8400021
  - Scottsdale, Arizona, United States, 85258
    - Recruiting
    - One of a Kind Clinical Research Center LLC - Site Number: 8400061
  - Tucson, Arizona, United States, 85715
    - Recruiting
    - Del Sol Research Management, LLC - Site Number: 8400012
- Arkansas
  - Little Rock, Arkansas, United States, 72211
    - Recruiting
    - Preferred Research Partners - Site Number: 8400018
- California
  - Arcadia, California, United States, 91006
    - Recruiting
    - FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
  - Canoga Park, California, United States, 91304
    - Recruiting
    - Alliance Research Institute - Site Number: 8400008
  - Coronado, California, United States, 92118-1408
    - Recruiting
    - Southern California GI & Liver Centers - Site Number: 8400062
  - Folsom, California, United States, 95630
    - Recruiting
    - GMC Clinical Research, LLC - Site Number: 8400113
  - Los Angeles, California, United States, 90048
    - Recruiting
    - TLC Clinical Research Inc. - Site Number: 8400030
  - Murrieta, California, United States, 92563
    - Recruiting
    - United Medical Doctors CA - Site Number: 8400044
  - San Diego, California, United States, 92123
    - Recruiting
    - Medical Associates Research Group - Site Number: 8400063
  - Santa Maria, California, United States, 93458
    - Recruiting
    - Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
  - Tarzana, California, United States, 91356
    - Recruiting
    - Valiance Clinical Research - Tarzana - Site Number: 8400023
  - Thousand Oaks, California, United States, 91360
    - Recruiting
    - Clinical Trials Management Services - Site Number: 8400047
  - Valencia, California, United States, 91355
    - Recruiting
    - Amicis Research Center-Valencia -Site Number: 8400064
  - Victorville, California, United States, 92395
    - Recruiting
    - Om Research, LLC - Victorville - Site Number: 8400022
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Recruiting
    - Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
  - Denver, Colorado, United States, 80218
    - Recruiting
    - Gastroenterology of the Rockies - Denver - Site Number: 8400122
- Florida
  - Clermont, Florida, United States, 32803
    - Recruiting
    - Novum Research, LLC - Site Number: 8400003
  - Coral Springs, Florida, United States, 33065
    - Recruiting
    - Precision Clinical Research-Site Number: 8400059
  - Gainesville, Florida, United States, 32607
    - Recruiting
    - Sarkis Clinical Trials-Ocala - Site Number: 8400048
  - Kissimmee, Florida, United States, 34741
    - Recruiting
    - Clinical Research of Osceola - Site Number: 8400013
  - Miami, Florida, United States, 33186
    - Recruiting
    - Correa Research Center-Site Number: 8400010
  - Miami, Florida, United States, 33125
    - Recruiting
    - Columbus Clinical Services LLc - Site Number: 8400038
  - Miami, Florida, United States, 33126
    - Recruiting
    - Regis Clinical Research, LLC - Site Number: 8400041
  - Miami, Florida, United States, 33155
    - Recruiting
    - Bio Research Partner - Site Number: 8400053
  - Miami, Florida, United States, 33165
    - Recruiting
    - Medical Professional Clinical Research Center - Site Number: 8400119
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Orlando Health, Inc. - Site Number: 8400084
  - Palmetto Bay, Florida, United States, 33176
    - Recruiting
    - Tropical Clinical Trials - Site Number: 8400082
  - Tampa, Florida, United States, 33607
    - Recruiting
    - NMC Research LLC - Site Number: 8400033
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Atlanta Gastroenterology Associates - Site Number: 8400109
  - Sandy Springs, Georgia, United States, 30328
    - Recruiting
    - M3 Wake Research - Atlanta - Site Number: 8400028
  - Snellville, Georgia, United States, 30078
    - Recruiting
    - EBGS Clinical Research Center, LLC - Site Number: 8400037
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Recruiting
    - Grand Teton Research Group, PLLC - Site Number: 8400127
- Illinois
  - Des Plaines, Illinois, United States, 60016
    - Recruiting
    - Midwest Digestive Health and Nutrition - Site Number: 8400136
  - Glenview, Illinois, United States, 60026
    - Recruiting
    - GI Alliance - Glenview - Site Number: 8400068
  - Gurnee, Illinois, United States, 60031
    - Recruiting
    - Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
- Indiana
  - New Albany, Indiana, United States, 47150
    - Recruiting
    - Gastroenterology Health Partners, PLLC - Site Number: 8400100
- Iowa
  - Waterloo, Iowa, United States, 50701
    - Recruiting
    - Cedar Valley Digestive Health Center - Site Number: 8400096
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Recruiting
    - GI Alliance - Baton Rouge - Site Number: 8400129
  - Houma, Louisiana, United States, 70072
    - Recruiting
    - Tandem Intermediate, LLC - Houma -Site Number: 8400034
  - Mandeville, Louisiana, United States, 70471
    - Recruiting
    - GastroGroup - Site Number: 8400128
  - Marrero, Louisiana, United States, 70072
    - Recruiting
    - Tandem Clinical Research - Marrero - Site Number: 8400002
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - GI Alliance - Metairie - Site Number: 8400124
  - Monroe, Louisiana, United States, 71291
    - Recruiting
    - Delta Research Partners
  - New Iberia, Louisiana, United States, 70560
    - Recruiting
    - Care Access - New Iberia - Site Number: 8400031
- Maryland
  - Greenbelt, Maryland, United States, 20770
    - Recruiting
    - Mid-Atlantic GI Research, LLC - Site Number: 8400106
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - Recruiting
    - UMass Memorial Medical Center - Site Number: 8400121
- Michigan
  - Wyoming, Michigan, United States, 49519
    - Recruiting
    - Gastroenterology Associates of Western Michigan - Site Number: 8400060
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Recruiting
    - Gateway Gastroenterology - Site Number: 8400097
  - Liberty, Missouri, United States, 64068
    - Recruiting
    - BVL Clinical Research - Site Number: 8400005
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Recruiting
    - Las Vegas Clinical Trials - Site Number: 8400079
  - Mesquite, Nevada, United States, 75043
    - Recruiting
    - SMS Clinical Research - Site Number: 8400035
- New Jersey
  - East Orange, New Jersey, United States, 07018
    - Recruiting
    - Sanmora Bespoke Clinical Research Solutions LLC - Site Number: 8400123
  - Freehold, New Jersey, United States, 07728
    - Recruiting
    - Allied Health Clinical Research Organization, LLC - Freehold - Site Number: 8400014
  - Jackson, New Jersey, United States, 08527
    - Recruiting
    - Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007
  - Somers Point, New Jersey, United States, 08244
    - Recruiting
    - Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
  - Sparta, New Jersey, United States, 07871
    - Recruiting
    - Premier Health Research, LLC - Site Number: 8400114
- New York
  - Maspeth, New York, United States, 11378
    - Recruiting
    - MedTraits NY - Site Number: 8400045
  - New York, New York, United States, 10075
    - Recruiting
    - New York Gastroenterology Associates - Site Number: 8400009
  - New York, New York, United States, 10016
    - Recruiting
    - Manhattan Clinical Research, LLC - Site Number: 8400069
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Langone Health - Site Number: 8400091
  - New York, New York, United States, 10065
    - Recruiting
    - Weill Cornell Medical College - NewYork-Presbyterian Hospital - Site Number: 8400040
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Recruiting
    - UNC Hospitals, The University of North Carolina at Chapel Hill - Site Number: 8400074
  - Charlotte, North Carolina, United States, 28211
    - Recruiting
    - OnSite Clinical Solutions - Site Number: 8400051
  - Fayetteville, North Carolina, United States, 28304
    - Recruiting
    - Cross Creek Medical Clinic - Site Number: 8400057
  - Monroe, North Carolina, United States, 28112
    - Recruiting
    - Monroe Biomedical Research - Site Number: 8400046
  - Raleigh, North Carolina, United States, 27612
    - Recruiting
    - ClinTrial Research, LLC - Site Number: 8400043
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Recruiting
    - Plains Medical Clinic - Site Number: 8400078
- Ohio
  - Canton, Ohio, United States, 44718
    - Recruiting
    - Gastroenterology & Hepatology Specialists, Inc. - Site Number: 8400139
  - Columbus, Ohio, United States, 43202
    - Recruiting
    - Ohio Gastroenterology Group Inc. - Site Number: 8400006
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - OSU Wexner Medical Center - Site Number: 8400077
  - Dayton, Ohio, United States, 45414
    - Recruiting
    - DSI Research, LLC - Site Number: 8400115
  - Springboro, Ohio, United States, 45066
    - Recruiting
    - DSI Research, LLC - Site Number: 8400105
  - Westlake, Ohio, United States, 44145
    - Recruiting
    - North Shore Gastroenterology Research - Site Number: 8400130
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Recruiting
    - Central Sooner Research - Site Number: 8400094
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-6243
    - Recruiting
    - University of Pennsylvania School of Medicine - Site Number: 8400072
  - Pittsburgh, Pennsylvania, United States, 15212
    - Recruiting
    - The Allegheny Health Network (AHN) Center for Digestive Health - Site Number: 8400107
- Rhode Island
  - Providence, Rhode Island, United States, 02904
    - Recruiting
    - University Gastroenterology - GI Alliance - Site Number: 8400103
- South Carolina
  - West Columbia, South Carolina, United States, 29169
    - Recruiting
    - Biocentric Health Research Partner
- Texas
  - Harlingen, Texas, United States, 78550
    - Recruiting
    - Valley Institute of Research - Site Number: 8400004
  - Kingwood, Texas, United States, 77339
    - Recruiting
    - One of a Kind Clinical Research Center LLC - Texas - Site Number: 8400125
  - Lake Jackson, Texas, United States, 77566
    - Recruiting
    - Innovare Research Group - Site Number: 8400067
  - Lubbock, Texas, United States, 79410
    - Recruiting
    - Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Gastroenterology Research of San Antonio LLC - Site Number: 8400054
  - Southlake, Texas, United States, 76092
    - Recruiting
    - Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
  - Tomball, Texas, United States, 77375
    - Recruiting
    - Texas Gastro Consultants - Site Number: 8400029
  - Tyler, Texas, United States, 75701
    - Recruiting
    - Tyler Research Institute, LLC - Site Number: 8400095
- Virginia
  - Lynchburg, Virginia, United States, 24502
    - Recruiting
    - Blue Ridge Medical Research - Site Number: 8400020
  - Richmond, Virginia, United States, 23226
    - Recruiting
    - Clinical Research Partners - Site Number: 8400080
- Washington
  - Vancouver, Washington, United States, 98664
    - Recruiting
    - The Vancouver Clinic Inc. P.S. - Site Number: 8400090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

Exclusion Criteria:

Participants with Crohn's Disease (CD), indeterminate colitis
Current diagnosis of Ulcerative Proctitis
Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections
Prior or current high-grade gastrointestinal (GI) dysplasia
Participants on treatment with but not on stable doses of conventional therapies prior to baseline
Participants with prohibited medications or therapies prior to baseline
Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo SC injection as per protocol	Drug: Placebo Pharmaceutical form:Solution for injection-Route of administration:SC injection
Experimental: Duvakitug - dose 1 Subcutaneous (SC) injection as per protocol	Drug: Duvakitug Pharmaceutical form:Solution for Injection-Route of administration:SC injection Other Names: SAR447189
Experimental: Duvakitug - dose 2 SC injection as per protocol	Drug: Duvakitug Pharmaceutical form:Solution for Injection-Route of administration:SC injection Other Names: SAR447189

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving clinical remission. Time Frame: Week 12	Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving clinical response by modified Mayo Score (mMS). Time Frame: Week 12	Clinical response is defined as a decrease from baseline in the mMS of ≥2 points and at least a 30% reduction from baseline, and a decrease in RB subscore of ≥1 or an absolute RB subscore of 0 or 1. mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.	Week 12
Proportion of participants achieving histological endoscopic mucosal improvement. Time Frame: Week 12	Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score ≤3.1. The Geboes score has 6 grades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	Week 12
Change from baseline in PROMIS-Fatigue Short Form 7a T-score. Time Frame: Baseline, Week 12	The PROMIS-Fatigue Short Form 7 is a tool that assessesfatigue severity and its impact on daily functioning over the past week.	Baseline, Week 12
Proportion of participants with symptomatic (SFS and RBS) remission Time Frame: Week 12	Symptomatic remission (SF and RB): stool-frequency sub score (SFS ) of 0 or 1, and rectal bleeding sub score (RBS) of 0.	Week 12
Proportion of participants with no bowel urgency. Time Frame: Week 12	The NRS for bowel urgency is a patient-reported tool designed to measure the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, where 0 represents "no urgency" and 10 signifies the "worst possible urgency".	Week 12
Proportion of participants reporting no nocturnal bowel movements. Time Frame: Week 12		Week 12
Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission. Time Frame: Week 4	Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.	Week 4
Proportion of participants who achieve endoscopic remission. Time Frame: Week 12	Endoscopic remission is defined as mMES of 0.	Week 12
Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS). Time Frame: Week 12	The abdominal pain NRS is a tool to rate the severity of abdominal pain over the past 24 hours using a score of 0 ("no pain") to 10 ("worst possible pain").	Week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score. Time Frame: Baseline, Week 12	IBDQ is a tool to the quality of life of individuals suffering from IBD. The total score ranges from 32 to 224, with higher scores correlating to a better quality of life.	Baseline, Week 12
Proportion of participants with UC-related hospitalization. Time Frame: Baseline through Week 12		Baseline through Week 12
Proportion of participants achieving clinical remission and no steroid use. Time Frame: Week 12		Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation. Time Frame: Baseline through 45 days after last dose		Baseline through 45 days after last dose
Serum concentration of duvakitug measured over time. Time Frame: Baseline through Week 12		Baseline through Week 12
Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug. Time Frame: Baseline through Week 12		Baseline through Week 12
Proportion of participants who achieve endoscopic improvement. Time Frame: Week 12	Endoscopic improvement is defined as MES of 0 or 1 (score of 1 excludes friability). Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Teva Branded Pharmaceutical Products R&D LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

EFC18325 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2025

Primary Completion (Estimated)

May 9, 2028

Study Completion (Estimated)

May 9, 2028

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

September 15, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC18325
2025-521035-37 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Ulcerative Colitis

Clinical Trials on Placebo

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Conditions

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